An observational study in Breast Cancer Patients, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to female participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by IRCCS SYNLAB SDN · Observational
Among 886 studies in Breast Neoplasms with a site in Italy — 230 open to participants now, 350 under way, 86 of them phase 3. Breast Neoplasms · Italy.
Among the 886 studies in Breast Neoplasms with a site in Italy, this one is the 36th largest by planned enrollment of the 195 observational ones that give a count, is one of 45 that started in 2019, is one of 196 observational ones, reaches primary completion later than 17 of the 349 other live ones, and was the 630th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →230 of the 886 studies in Breast Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
Daiichi Sankyo · Sites in Italy, United States, Belgium and 5 more countries
Ages 18+
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+ · Women only
UNICANCER · Sites in Italy, Belgium, France and 4 more countries
Ages 35–45 · Women only
Massimiliano Bortolini · Sites in Italy
Ages 18–75 · Women only
AstraZeneca · Sites in Italy, United States, France and 6 more countries
Ages 18–130
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 25 Years to 80 Years · female.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
886 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 234 · Phase 3 239 · Phase 4 13
First in 1993; this study’s year is marked. 45 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 209 across the 686 interventional studies, 256 across the 195 observational. Of the 457 that completed or were terminated, 222 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
417 of 886 have an industry lead sponsor. The 10 most frequent:
IRCCS SYNLAB SDN is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
IRCCS SYNLAB SDN has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
83 of the studies in Breast Neoplasms with a site in Italy that are under way reach primary completion within a year, 21 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT03595592Phase 3Fondazione MichelangeloNeoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer | 2026-12-15 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
Add all 83 to your calendar (.ics) → With an account.
Among the 886 studies in Breast Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer
Breast cancer patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At the time of surgery, having completed the evaluation extemporaneous of the surgical piece, tissue samples will be collected to be stored from the material exceeding the completion of the patients' diagnosis. In addition, paramenters that can be extracted from radiodiagnostic images will be evaluated
Multiparametric flow cytometry analyses of Custer of Differentiation (CD) proteins expression on tumor infiltrating lymphocytes
The following phase of the study aims to go to evaluate the immunology of breast cancer patients compared with the control. In particular we will perfome an accurate characterization in flow cytometry of the cells present in the peripheral blood and of the immune component infiltrating the tumor (tumor infiltrating lymphocytes). The different components of tumor infiltrating lymphocytes will be assessed using the following antibodies: CD45 , CD8, CD4,CD3, HLA-DR, CD19 , CD 326 (EpCAM) ,CD56 , CD14 and CD16.
Time frame: 1-24 months
Analysis of gene expression profiles of cancer cells
The following area of study is focused on the study by molecular biology of samples of cancerous and healthy tissue that will be possible to obtain from the subjects participating in the study. For that phase, the type of instrumentation will be determined according to the amount of nucleic acids extracted from the tissues. In fact, samples that will allow recovery of high amounts of RNA and with a good degree of purity will be able to be used for studies carried out with next generation sequencing such as, for example, Ion Torrent S5. In the case of samples in which the RNA is difficult to extract or of low quality, methods such as real time polymerase chain reaction (PCR) in multiplex mode
Time frame: 1-24 months
Extraction of features from radiological images to be used as biomarkers.
Radiological images from High-field MRI, multilayer CT, hybrid systems such as PET-CT and PET-MRI will be use to extract quantitative parameters of the lesion and the other structures of interest. An automatic segmentation , or alternatively, a manual segmentation by an experienced radiologist or experienced nuclear physician will be performe.
Time frame: 1-36 months
Bioinformatics analysis
The correlations between the cytofluorimetric characterization of TILs and the quantitative parameters extracted from radiological images will be performed using different software such as Graphpad or ER softwares.
Time frame: 37-48 months
Ran from May 2019 to primary completion in Jan 2023, 44 months.
Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's 44 months is below that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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IRCCS SYNLAB SDN